Software should simplify, not complicate.
We’ve all been there. Your company implements a quality management software system that is supposed to make things efficient, and instead everyone gets bogged down in ineffective workflows and systems that require extensive step-by-step manuals to maneuver through. It’s painful.
As quality practitioners in regulated industries, our focus needs to be on compliance - ensuring effective document control, thorough CAPAs, and timely and complete complaints for reporting, just to name a few. Ultimately, the quality management system needs to work like a well-oiled machine. The last thing we need to deal with are inefficient and ineffective systems that put compliance at risk.
Until recently, I was in your shoes. Across several roles I used many different quality management systems, document control software packages, ERPs, and training software systems, all while trying to adhere to regulatory requirements, ISO standards, and internal SOPs. I never did find a system that was fully integrated and easy-to-use. Systems that were compliant were cumbersome, the ones that were easy-to-use were not compliant, and most systems were not well integrated, if at all.
In my frustration, I wondered if QMS software companies ever took the time to solicit feedback from their customers or employed people with quality backgrounds, since what they were doing clearly wasn’t working. Therefore I was pleasantly surprised when a company reached out to me with hopes of hiring a person with a broad quality background to offer a customer’s perspective on the challenges quality professionals experience with using QMS software. This individual would provide user feedback to make the quality practitioner’s job easier and build a QMS system that is both efficient and effective. That company was Veeva Systems.
I jumped at the opportunity to convey quality personnel’s struggles and influence the creation of an integrated system that was easy-to-use and practical. Our team was committed to building a system that aided the quality person’s many tasks, not hinder them. A system that was fast and harnessed the latest technology to improve the user’s experience while lowering the cost of quality.
The result of our work is Vault QualityOne. This system allows for integration between document control and quality management processes. This unified application will allow companies to gain significant efficiencies in previously fragmented processes like change control, CAPAs, Audits, and Supplier Quality Management. The application is hosted on Veeva’s Vault Platform, which has proven itself in the life sciences industry and is expanding its offerings to other industries.
I look forward to working with Veeva for every quality practitioner out there to ensure an easy-to-use and compliant system is available to simplify quality work, not complicate it.
Sophia Finn has over 10 years of quality experience in regulated industries. She began her career with the FDA working in CBER’s vaccine lot release program and later moved to the FDA's office of regulatory affairs as a regulatory microbiologist. Additionally, Sophia has managed CAPA, complaints, audit, and deviation programs in the medical device industry. Sophia has a master of science in bioscience in regulatory affairs from Johns Hopkins University and is an ASQ Certified Quality Auditor.